NDA 213478

NOBELPHARMA CO., LTD.

FDA Drug Application

Application #213478

Documents

• Letter: 2022-03-23
• Label: 2022-03-25
• Review: 2022-05-19

Application Sponsors

NDA 213478

NOBELPHARMA CO., LTD.

Marketing Status

• Prescription: 001

Application Products

001

GEL; TOPICAL

0.2%

0

HYFTOR

SIROLIMUS

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

2022-03-22

PRIORITY

Submissions Property Types

ORIG

1

Null

30

CDER Filings

NOBELPHARMA CO., LTD.

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(
    [0] => Array
        (
            [ApplNo] => 213478
            [companyName] => NOBELPHARMA CO., LTD.
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYFTOR","activeIngredients":"SIROLIMUS","strength":"0.2%","dosageForm":"GEL; TOPICAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"03\/22\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/213478s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/22\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/213478s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/213478Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-03-22
        )

)